JP5926453B2 - Lead having tip electrode for electrical stimulation system and method of making and using the same - Google Patents

Lead having tip electrode for electrical stimulation system and method of making and using the same Download PDF

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JP5926453B2
JP5926453B2 JP2015515232A JP2015515232A JP5926453B2 JP 5926453 B2 JP5926453 B2 JP 5926453B2 JP 2015515232 A JP2015515232 A JP 2015515232A JP 2015515232 A JP2015515232 A JP 2015515232A JP 5926453 B2 JP5926453 B2 JP 5926453B2
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lead
electrode
plurality
electrodes
lumen
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JP2015517883A (en
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アン マーガレット ピアンカ
アン マーガレット ピアンカ
ジョシュア デイル ハワード
ジョシュア デイル ハワード
ウィリアム ジョージ オリンスキ
ウィリアム ジョージ オリンスキ
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ボストン サイエンティフィック ニューロモデュレイション コーポレイション
ボストン サイエンティフィック ニューロモデュレイション コーポレイション
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Priority to US61/654,579 priority
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Priority to PCT/US2013/043588 priority patent/WO2013181519A2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0529Electrodes for brain stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0529Electrodes for brain stimulation
    • A61N1/0534Electrodes for deep brain stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/0565Electrode heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system

Description

(Cross-reference of related applications)
This application claims priority from US Provisional Patent Application No. 61 / 654,579, filed June 1, 2012, the contents of which are incorporated herein by reference.

  The present invention relates to the field of electrical stimulation systems and methods of making and using such systems. The present invention also relates to an electrical stimulation lead having a tip electrode designed to facilitate retention of the tip electrode on the distal end of the lead, and a method of making and using the lead and electrical stimulation system.

  Electrical stimulation can be useful for treating various diseases. Deep brain stimulation is useful for treating, for example, Parkinson's disease, dystonia, essential tremor, chronic pain, Huntington's disease, levodopa-induced dyskinesia and stiffness, slow movement, epilepsy and seizures, eating disorders, and mood disorders possible. Typically, a lead having a stimulation electrode at or near the tip of the lead provides stimulation to the target nerves in the brain. Magnetic resonance imaging (“MRI”) or computed tomography (“CT”) scanning provides a starting point for positioning the stimulation electrodes and determining the site where the desired stimulation should be delivered to the target nerve.

US Pat. No. 7,809,446 US Patent Application Publication No. 2007/0150036 US Patent Application Publication No. 2009/0187222 US Patent Application Publication No. 2009/0276021 US Patent Application Publication No. 2010/0076535 US Patent Application Publication No. 2010/0268298 US Patent Application Publication No. 2011/0078900 US patent application Ser. No. 12 / 177,823 US Patent Application No. 61 / 022,953 U.S. Patent Application No. 61 / 316,759 U.S. Pat. No. 8,295,944 US Pat. No. 8,391,985 US Patent Application Publication No. 2010/0268298 US Patent Application Publication No. 2011-0005069 US Patent Application Publication No. 2011/0078900 US Patent Application Publication No. 2011/0130817 US Patent Application Publication No. 2011/0130818 US Patent Application Publication No. 2011/0238129 US Patent Application Publication No. 2011/0313500 US Patent Application Publication No. 2012/0016378 US Patent Application Publication No. 2012/0046710 US Patent Application Publication No. 2012/0165911 US Patent Application Publication No. 2012/0197375 US Patent Application Publication No. 2012/0203316 US Patent Application Publication No. 2012/0203320 US Patent Application Publication No. 2012/0203321 U.S. Patent Application No. 13 / 750,725 U.S. Patent Application No. 13 / 787,171

  After the lead is implanted in the patient's brain, an electrical stimulation current can be delivered through a selection electrode on the lead to stimulate the target nerve in the brain. Typically, the electrode is formed in a ring disposed on the distal portion of the lead. Stimulation current is emitted from the ring electrode in all directions as well. Because of the ring shape of these electrodes, the stimulating current can be applied to one or more specific locations around the ring electrode (eg, around one or more sides or points, around the lead). To). As a result, undirected stimulation may result in unwanted stimulation of adjacent neural tissue and in some cases undesirable side effects.

  One embodiment includes a lead body having a distal portion, a distal tip, and a proximal portion, a plurality of electrodes disposed along the distal portion of the lead body, and disposed along the proximal portion of the lead. An implantable electrical stimulation lead comprising a plurality of terminals and a plurality of conductors, each conductor electrically coupling at least one electrode to the at least one terminal. The plurality of electrodes includes a tip electrode disposed on the distal tip of the lead body. The chip electrode has a base and a separation plug attached to the base. The base has a lumen that is closed at one end by a plug. A portion of the lead body extends into the base lumen.

  Another embodiment includes a lead body having a distal portion, a distal tip, and a proximal portion, a plurality of electrodes disposed along the distal portion of the lead body, and disposed along the proximal portion of the lead. An implantable electrical stimulation lead comprising a plurality of terminals and a plurality of conductors, each conductor electrically coupling at least one electrode to the at least one terminal. The plurality of electrodes includes a tip electrode disposed on the distal tip of the lead body. The chip electrode includes an electrode main body, a stem extending from the electrode main body, and a plurality of holding shape portions extending from the stem. A portion of the lead body extends around the stem and the retaining feature. The holding shape portion facilitates holding of the chip electrode in the lead body.

  Yet another embodiment includes a lead body having a distal portion, a distal tip, and a proximal portion, a plurality of electrodes disposed along the distal portion of the lead body, and along the proximal portion of the lead. An implantable electrical stimulation lead including a plurality of terminals disposed and a plurality of conductors, each conductor electrically coupling at least one electrode to the at least one terminal. The plurality of electrodes includes a tip electrode disposed on the distal tip of the lead body. The tip electrode has an electrode body, a stem extending from the electrode body, and a flange mounted on the stem on the opposite side of the electrode body. A portion of the lead body extends around the stem and the flange. The flange facilitates holding of the chip electrode in the lead body.

  Another embodiment includes a lead body having a distal portion, a distal tip, and a proximal portion, a plurality of electrodes disposed along the distal portion of the lead body, and disposed along the proximal portion of the lead. An implantable electrical stimulation lead comprising a plurality of terminals and a plurality of conductors, each conductor electrically coupling at least one electrode to the at least one terminal. The plurality of electrodes includes a tip electrode disposed on the distal tip of the lead body. The tip electrode has an electrode body, and the electrode body has a lumen and a plurality of protrusions extending into the lumen. A portion of the lead body extends into the lumen of the electrode body. The plurality of projections within the lumen facilitates retention of the tip electrode in the lead body and prevents rotation of the tip electrode about the distal tip of the lead body.

  Another embodiment includes a lead body that includes a distal portion, a distal tip, and a proximal portion, a plurality of electrodes disposed along the distal portion of the lead body, and disposed along the proximal portion of the lead. An implantable electrical stimulation lead comprising a plurality of terminals and a plurality of conductors, each conductor electrically coupling at least one electrode to the at least one terminal. The plurality of electrodes includes a tip electrode disposed on the distal tip of the lead body. The chip electrode has an electrode body and a plurality of arms extending from the electrode body. The electrode body has a lumen and an opening to the lumen. The plurality of arms extend over the lumen opening. A portion of the lead body extends into the lumen of the electrode body and around the plurality of arms. The plurality of arms facilitates holding of the chip electrode in the lead body.

  Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified.

  For a better understanding of the present invention, reference is made to the following “Detailed Description” which should be read in conjunction with the accompanying drawings.

1 is a schematic side view of one embodiment of a device for brain stimulation according to the present invention. FIG. FIG. 3 is a schematic perspective view of one embodiment of a portion of a lead having a plurality of segment electrodes and a chip electrode according to the present invention. FIG. 6 is a schematic perspective view of a second embodiment of a portion of a lead having a plurality of segment electrodes and chip electrodes according to the present invention. FIG. 6 is a schematic diagram of radial current steering along various electrode levels along the length of a lead according to the present invention. 1 is a schematic cross-sectional view of one embodiment of a two-piece tip electrode according to the present invention. FIG. 4 is a schematic side view of one embodiment of a portion of a lead having a two-piece tip electrode before joining the two pieces together according to the present invention. FIG. 6B is a schematic side view of a portion of the lead of FIG. 6A with two pieces of chip electrodes coupled together according to the present invention. 1 is a schematic cross-sectional view of one embodiment of a tip electrode having a stem according to the present invention. FIG. 1 is a schematic perspective view of one embodiment of a tip electrode having a stem and a flange according to the present invention. FIG. FIG. 8B is a schematic perspective view of one embodiment of a pre-electrode that can be ground to form the tip electrode of FIG. 8A according to the present invention. 1 is a schematic perspective view of one embodiment of a tip electrode having a shaped lumen according to the present invention. FIG. FIG. 9B is a schematic perspective view of one embodiment of a pre-electrode that can be ground to form the tip electrode of FIG. 9A according to the present invention. 1 is a schematic perspective view of one embodiment of a tip electrode having a lumen and a plurality of arms extending from the edge of the electrode over the lumen opening, in accordance with the present invention. FIG. FIG. 10B is a schematic perspective view of one embodiment of a pre-electrode that can be ground to form the tip electrode of FIG. 10A in accordance with the present invention.

  The present invention relates to the field of electrical stimulation systems and methods of making and using the systems. The present invention also relates to an electrical stimulation lead having a tip electrode designed to facilitate retention of the tip electrode on the distal end of the lead, and a method of making and using the lead and electrical stimulation system.

  Leads for deep brain stimulation can include stimulation electrodes, recording electrodes, or a combination of both. In at least some embodiments, the stimulation or recording electrode of the lead can include a tip electrode and one or more ring or segment electrodes or any combination thereof. In at least some embodiments, at least some of the stimulation electrodes, recording electrodes, or both are provided in the form of segment electrodes that extend only partially around the circumference of the lead. In some embodiments, these segment electrodes can be provided in sets of electrodes, each set having electrodes distributed radially around the leads at a particular longitudinal position. In some embodiments, the segment electrodes are, for example, arranged in one or more spirals around the circumference of the lead, or arranged only along one side of the lead. Can be provided in any other suitable arrangement.

  The practitioner can use the recording electrode to determine the location of the target nerve and then position the stimulation electrode according to the result without removing the recording lead and inserting the stimulation lead. In some embodiments, the same electrode can be used for both recording and stimulation. In some embodiments, a separate lead can be used, the first lead has a recording electrode that identifies the target nerve, the second lead has a stimulation electrode, and after identification of the target nerve, Replace the second lead with the first lead. The lead can include recording electrodes spaced apart around the outer periphery of the lead to more accurately determine the location of the target nerve. In at least some embodiments, the lead is rotatable so that the stimulation electrode can be aligned with the target nerve after the recording electrode is used to locate the nerve. For illustrative purposes, leads are described herein for use in deep brain stimulation, but any of the leads can be used for spinal cord stimulation, dorsal root ganglion stimulation, and other nerve, muscle tissue or organ stimulation. It should be understood that it can be used for applications other than deep brain stimulation, including but not limited to.

  Deep brain stimulation devices and leads are described in, for example, Patent Documents 1 to 10. Each of these documents is incorporated herein by reference.

  FIG. 1 shows one embodiment of a device 100 for brain stimulation. The device includes a lead 110, a plurality of electrodes 125 disposed at least partially on the periphery of the lead 110, a plurality of terminals 135, a connector 130 for connecting the electrodes to the control unit, and the leads to the patient's brain. A stylet 140 is included to help insert and position it. The stylet 140 may be made of a rigid material. Examples of suitable materials for the stylet include, but are not limited to, tungsten, stainless steel, and plastic. The stylet 140 can have a handle 150 to assist in insertion into the lead 110 and rotation of the stylet 140 and lead 110. Connector 130 is preferably mounted over the proximal end of lead 110 after stylet 140 is removed.

  The control unit (not shown) is typically an implantable pulse generator that can be implanted in the patient's body, for example, under the patient's clavicle region. The pulse generator can have eight stimulation channels, and the stimulation channels can be independently programmable to control the magnitude of the current stimulus from each channel. In some cases, the pulse generator may have more than eight stimulation channels (eg, 16, 32, or more stimulation channels). The control unit can have one, two, three, four, or more connector ports that accept a plurality of terminals 135 at the proximal end of the lead 110.

  In one example of operation, access to the desired location in the brain is achieved by using a skull drill (usually called a bar) to drill a hole in the patient's skull or skull to coagulate and incise the dura mater or brain covering. Is done. The lead 110 can be inserted into the skull and brain tissue with the aid of the stylet 140. For example, a stereotaxic frame and a microdrive motor system can be used to guide the lead 110 to a target location in the brain. In some embodiments, the microdrive motor system may be fully automatic or semi-automatic. The microdrive motor system may be configured to perform one or more (single or combined) of lead 110 insertion, lead 110 retraction, or lead 110 rotation. .

  In some embodiments, a measurement device coupled to muscle or other tissue stimulated by a target nerve, or a unit responsive to a patient or clinician can be coupled to a control unit or a microdrive motor system. . A measurement device, user, or clinician can indicate a response by the target muscle or other tissue to the stimulation or recording electrode to further identify the target nerve and facilitate positioning of the stimulation electrode. For example, if the target nerve is directed to a tremored muscle, the measurement device can be used to observe the muscle and show changes in tremor frequency or amplitude in response to nerve stimulation. . As a variant, the patient or clinician may observe the muscle and provide feedback.

  Lead 110 for deep brain stimulation can include stimulation electrodes, recording electrodes, or both. In at least some embodiments, the lead 110 is rotatable so that the stimulation electrode can be aligned with the target nerve after the nerve is positioned using the recording electrode.

  The stimulation electrode is disposed on the outer periphery of the lead 110 and stimulates the target nerve. The stimulation electrodes may be ring shaped so that current is emitted equally from all electrodes from the position of the electrodes along the length of the lead 110 in all directions. However, ring electrodes typically cannot direct stimulation current to only one side of the lead. However, with segment electrodes, the stimulation current can be directed to one side of the lead and even to a portion of one side. When a segmented electrode is used with an implantable pulse generator that delivers a constant current stimulus, current steering that delivers the stimulus precisely to a location around the lead axis (ie, radial around the lead axis) Positioning) can be achieved.

  In order to achieve current steering, segment electrodes may be utilized in addition to or as an alternative to the ring electrodes. In the following description, stimulation electrodes are described, but it should be understood that all configurations of the stimulation electrodes described can also be used to arrange recording electrodes.

  2 and 3 show an embodiment of the distal portion of a lead 200 for brain stimulation. The lead 200 includes a lead body 210, one or more optional ring electrodes 220, a plurality of segment electrodes 230, and a tip electrode 240. It should be understood that other lead embodiments may include only the tip electrode and one or more ring electrodes, or only the tip electrode and one or more segment electrodes. Other embodiments may include a combination of tip and ring electrodes and segment electrodes in an arrangement other than that shown in FIGS.

  The lead body 210 can be formed of a biocompatible non-conductive material such as, for example, a polymer material. Suitable polymeric materials include, but are not limited to, silicones, polyurethanes, polyureas, polyurethaneureas, polyethylenes, or the like. Once the lead 200 is implanted in the body, the lead 200 can contact body tissue for an extended period of time. In at least some embodiments, the lead 200 has a cross-sectional diameter not greater than 1.5 mm and can range from 1 mm to 1.5 mm. In at least some embodiments, the lead 200 has a length of at least 10 cm, and the length of the lead 200 can be in the range of 25 cm to 70 cm.

  The electrodes 220, 230, 240 can be made using metals, alloys, conductive oxides, or any other suitable conductive biocompatible material. Examples of suitable materials include, but are not limited to, platinum, platinum iridium alloys, iridium, titanium, tungsten, palladium, palladium rhodium, or the like. Preferably, the electrodes are made of a material that is biocompatible and does not substantially corrode under the expected operating conditions in the operating environment over the expected period of use.

  Each of the electrodes 220, 230, 240 may be used or not used (off). When the electrode is used, the electrode is used as an anode or a cathode, and can carry an anode or cathode current. In some cases, the electrode may be an anode over a period of time and a cathode over a period of time.

  A stimulation electrode in the form of a ring electrode 220 can typically be placed on any portion of the lead body 210 near the distal end of the lead 200. A stimulation electrode in the form of a tip electrode 240 is disposed at the distal end of the lead. In FIG. 2, the lead 200 includes one ring electrode 220 and one tip electrode 240. For example, any number of rings including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or more ring electrodes 220 The electrode 220 can be disposed along the length direction of the lead body 210. It should be understood that any number of ring electrodes may be disposed along the length of the lead body 210.

  In some embodiments, the ring electrode 220 and the tip electrode 240 are substantially cylindrical and are wound around the entire outer periphery of the lead body 210. The tip electrode 240 also extends over the tip of the lead. In some embodiments, the outer diameters of the ring electrode 220 and the tip electrode 240 are independently substantially equal to the outer diameter of the lead body 210. The lengths of the ring electrode 220 and tip electrode 240 can be varied independently depending on the desired procedure and the location of the target nerve or other tissue. In some embodiments, the length of one or more of the ring electrode 220 and tip electrode 240 is less than or equal to the corresponding diameter of the ring electrode 220 and tip electrode 240. In other embodiments, the length of one or more of the ring electrode 220 and tip electrode is greater than the corresponding diameter of the ring electrode 220 and tip electrode 240. In at least some embodiments, the surface area of tip electrode 240 and one ring electrode 220 can be equal or substantially equal (eg, within 10% or 5% of each other).

  Deep brain stimulation leads and other leads can include one or more sets of segment electrodes. Segment electrodes can provide better current steering than ring electrodes because the deep brain target structure is typically not symmetric with respect to the axis of the distal electrode array. Instead, the target can be positioned on one side of the plane containing the lead axis. With the use of a radial segment electrode array (“RSEA”), current steering can be performed not only along the length of the lead but also around the outer periphery of the lead. This provides accurate three-dimensional target determination and delivery of current stimuli to neural target tissue, possibly avoiding other tissue stimulation. Examples of leads having segment electrodes include Patent Documents 11 to 26, all of which are incorporated herein by reference.

  In FIG. 2, a lead 200 having a plurality of segment electrodes 230 is shown. Any number of segment electrodes 230 may be disposed on the lead body 210, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or more segment electrodes 230 are included. It should be understood that any number of segment electrodes 230 may be disposed along the length of the lead body 210.

  The segment electrodes 230 can be grouped into sets of segment electrodes, where each set is disposed on the outer periphery of the lead 200 at a particular longitudinal portion of the lead 200. The lead 200 can have any number of segment electrodes 230 within a given set of segment electrodes. The lead 200 can have one, two, three, four, five, six, seven, eight, or more segment electrodes 230 in a given set. In at least some embodiments, each set of segment electrodes 230 of lead 200 includes the same number of segment electrodes 230. The segment electrode 230 disposed on the lead 200 may include a different number of electrodes from at least one other set of the segment electrodes 230 disposed on the lead 200.

  The size and shape of the segment electrode 230 can be varied. In some embodiments, all segment electrodes 230 have the same size, shape, diameter, width, or area, or any combination thereof. In some embodiments, each perimeter set of segment electrodes 230 (or all segment electrodes disposed on the leads 200) can be of the same size and shape.

  Each set of the segment electrodes 230 may be disposed on the outer periphery of the lead body 210 so as to form a substantially cylindrical shape around the lead body 210. The spacing between individual electrodes in a given set of segment electrodes may be the same or different from the spacing between individual electrodes in another set of segment electrodes on lead 200. In at least some embodiments, equal spaces, gaps, or notches are disposed between each segment electrode 230 on the outer periphery of the lead body 210. In other embodiments, the size or shape of the spaces, gaps, or notches between the segment electrodes 230 may be different. In other embodiments, the spaces, gaps, or notches between the segment electrodes 230 may be uniform for a particular set of segment electrodes 230 or for all sets of segment electrodes 230. The set of segment electrodes 230 may be positioned at irregular intervals along the length direction of the lead body 210 or may be positioned at regular intervals.

  Lead wires attached to the tip electrode, the ring electrode 220, and the segment electrode 230 extend along the lead body 210. These leads may extend through the material of the lead 200, may extend along one or more lumens defined by the lead 200, or both. Leads are presented at the connector (via terminals) to couple the electrodes 220, 230, 240 to a control unit (not shown).

  If the lead 200 includes a tip electrode 240, a ring electrode 220, and a segment electrode 230, the ring electrode 220 and the segment electrode 230 can be arranged in any suitable configuration. The tip electrode 240 will generally be placed at the distal tip of any arrangement that includes the tip electrode 240. For example, if the lead 200 includes a tip electrode 240, a ring electrode 220, and two sets of segment electrodes 230, the tip electrode 240 and the ring electrode 220 should be positioned next to the two sets of segment electrodes 230. (See, for example, FIG. 2). Alternatively, the tip electrode 240 and the ring electrode 220 may be disposed distal to the two sets of segment electrodes 230 (see, eg, FIG. 3). It should be understood that other configurations (eg, ring and segment electrodes are interleaved, etc.) are possible.

  Any combination of tip electrode 240, ring electrode 220, and segment electrode 230 can be disposed on lead 200. For example, the lead can include a ring electrode, two sets of segment electrodes, each set formed by three segment electrodes 230, and a tip electrode at the end of the lead. This configuration can be simply called a 1-3-3-1 configuration as shown in FIG. It may be useful to refer to the electrode by this abbreviation. FIG. 3 shows a lead having a 3-3-1-1 configuration. The feasible configuration for the 16-electrode lead having the chip electrode is not limited to the following, but is 3-3-3-3-3-1 and 1-3-3-3-3-3-3. 1 is included.

  Markers or other markings can be provided so that the practitioner can determine the orientation of the segment electrode when it is implanted. Examples of suitable markers and indicia can be found, for example, in US Pat.

  FIG. 4 is a schematic diagram showing radial current steering along various electrode levels along the length of lead 200. A conventional lead configuration with a ring electrode only allows current steering along the length of the lead (z-axis), whereas a segmented electrode configuration has current in the x-axis, y-axis, and z-axis. Steering is possible. Therefore, the center of gravity of the stimulus can be steered in an arbitrary direction in the three-dimensional space surrounding the lead 200. In some embodiments, the radial distance r and the circumferential angle θ of the lead 200 (recognizing that although the stimulation occurs primarily near the cathode, a strong anode can also cause stimulation). , Which can be indicated by the percentage of anode current introduced into each electrode. In at least some embodiments, the configuration of the anode and cathode along the segment electrode allows the stimulation centroid to be shifted to a variety of different positions along the lead 200.

  As can be appreciated from FIG. 4, the center of gravity of the stimulus can be shifted at each level along the length direction of the lead 200. The use of multiple sets of segment electrodes at different levels along the length of the lead allows for 3D current steering. In some embodiments, the set of segment electrodes is shifted together (ie, the stimulus centroid is similar at each level along the length of the lead). In at least some other embodiments, each set of segment electrodes is controlled independently. Each set of segment electrodes can include two, three, four, five, six, seven, eight, or more segment electrodes. It should be understood that different stimulation profiles can be generated by varying the number of segment electrodes at each level. For example, when each set of segment electrodes includes only two segment electrodes, a uniformly distributed gap (not selectively stimulable) can be formed in the stimulation profile. In some embodiments, utilizing at least three segment electrodes 230 in the set allows for true 360 ° selectivity.

  As indicated above, the configuration described above can also be used while utilizing recording electrodes. In some embodiments, a measurement device coupled to muscle or other tissue stimulated by a target nerve, or a unit responsive to a patient or clinician can be coupled to a control unit or a microdrive motor system. . A measurement device, user, or clinician can indicate a response by the target muscle or other tissue to the stimulation or recording electrode to further identify the target nerve and facilitate positioning of the stimulation electrode. For example, if the target nerve is directed to a tremored muscle, the measurement device can be used to observe the muscle and show changes in tremor frequency or amplitude in response to nerve stimulation. . As a variant, the patient or clinician may observe the muscle and provide feedback.

  The tip electrode can be used with one or more ring electrodes, one or more segment electrodes, or any combination of ring and segment electrodes. In at least some embodiments, the tip electrode can be selected to have the same or substantially the same surface area as one or more ring electrodes of the lead.

  The chip electrode can be designed to improve the retention of the chip electrode on the lead. For example, the tip electrode can have a hollow cylindrical base and a separation plug that can be attached to the base. FIG. 5 shows a tip electrode 540 having a base 542 and a separation plug 544. Base 542 and plug 544 are typically formed of a suitable metal, alloy, or other electrical conductor. The base 542 is a hollow tubular structure having a lumen 541 with openings at both ends of the tubular structure that allow material to flow through the base. Open lumen 541 facilitates retention of the base on the lead. Base 542 includes a distal opening 543 shaped to receive plug 544. In some embodiments, the base 542 has a beveled edge 545 in the distal opening 543 corresponding to the beveled edge 547 on the plug 544 to facilitate mating of the base and the plug.

  6A and 6B show the distal portion of one embodiment of a lead 500 having a tip electrode 540 with a base 542 and a separation plug 544. The lead also includes a lead body 510, 510 ′ and one or more additional electrodes 520. In at least some embodiments, the lead body 510 is between the electrodes 520 (and, in at least some embodiments, between the electrode and the terminal at the proximal end of the lead (see FIG. 1)). Formed by molding 510 '. The material of the lead body 510 can also be molded between the most distal electrode 520 and the base 542 of the tip electrode 540. During the molding process, the material that will form the lead body can flow into the lumen 541 of the base 542 (see FIG. 5). Any molding process can be used, including but not limited to injection molding. The lead body 510, 510 'can be formed of any material that can be shaped by flowing the material around other components and then solidifying the material to form the lead body. The material can be solidified using any suitable process including, but not limited to, material cooling, photocuring, heat curing, crosslinking, and the like. Examples of suitable materials include silicone, polyurethane, polyetheretherketone, and the like. As an example, the method of forming leads having segment electrodes disclosed in US Patent Application Publication No. 2011/0078900, incorporated herein by reference, is modified to include chip electrodes (eg, FIGS. 7A-7E). The distal most ring electrode can be replaced with a tip electrode).

  When lead body 510 is formed, the lead body extends into the lumen of base 542 to facilitate retention of tip electrode 540 on lead 500. After the lead body 510 is formed, the plug 544 can be welded, soldered, adhesive (preferably conductive adhesive), press fit, crimped, threaded on the base and plug, or any combination thereof, or It can be attached (preferably permanently) to the base 542 by any other suitable fastening mechanism. Preferably, plug 544 and base 542 are also in electrical communication with each other through a fastening mechanism. In at least some embodiments, a portion of the lead body can be removed from the distal opening 543 of the base 542 to allow attachment of the plug 544 to the base.

  A tip electrode conductor (not shown) is attached to the tip electrode 540, welded, soldered, or otherwise electrically coupled. The chip electrode conductors can be bonded before the lead body 510 is formed. The tip electrode conductor, like the other conductors in the lead, extends along the lead and is electrically coupled to one of the terminals located along the proximal end of the lead. In some embodiments, the tip electrode conductor is coupled to the base 542, for example, at the surface of the lumen 541 or at the proximal end of the base. In some embodiments, the tip electrode conductor is attached to the plug 544.

  The tip electrode can include a stem provided with one or more features to facilitate holding the tip electrode at the distal end of the lead. FIG. 7 shows a cross-section of one embodiment of a tip electrode 740 having an electrode body 742 and a stem 746 provided with a retention feature 748 formed on the stem. The electrode body 742 includes at least a portion of a surface that is exposed to tissue to stimulate the tissue when the lead is implanted. When the lead body is formed, the lead body material is formed around the stem of the chip electrode to facilitate retention of the chip electrode within the lead body of the resulting lead. The holding shape portion 748 prevents the chip electrode from coming off from the lead body. The retention feature 748 on the stem typically extends away from the portion of the stem 746 adjacent to it and interacts with the material at the distal end of the lead, such as the lead body, so that the distal end of the lead Resist the extraction of the tip electrode 740 from the end. Examples of suitable retention features include, but are not limited to, one or more stepped portions, inclined protrusions, flanges, teeth, protrusion threads, or the like formed on the stem Or a rough surface formed on the stem. In the embodiment shown in FIG. 7, the retention feature has an inclined surface 760 on one side and a stepped surface 762 on the other side to resist withdrawal from the distal end of the lead.

  A tip electrode conductor (not shown) is attached to the tip electrode 740, welded, soldered, or otherwise electrically coupled. In some embodiments, the tip electrode conductor is coupled to the stem 746. For example, the tip electrode conductor can be coupled to the side of the stem 746 or the proximal end of the stem. In other embodiments, the tip electrode conductor can be attached to the main portion of the tip electrode (ie, the non-stem portion of the tip electrode). The tip electrode conductor extends along the lead and is electrically coupled to one of the terminals disposed along the proximal end of the lead.

  FIG. 8A shows another embodiment of a tip electrode 840 that includes an electrode body 842 and a stem 846 having a flange 850 attached to the end of the stem. The electrode body 842 includes at least a portion of a surface that is exposed to tissue to stimulate the tissue when the lead is implanted. The flange can have any suitable shape including, but not limited to, a disk shape, a square shape, a hexagon shape, an octagon shape, a triangle shape, and the like. In the illustrated embodiment, the flange is in the form of a gear with a disc having regular depressions 852 formed in the sides of the disc leaving regular projections 854 around the edges of the disc. The tip electrode conductor (not shown) can be attached to any portion of the tip electrode including, but not limited to, flange 850, flange protrusion 854, or recess 852 in the flange.

  When the lead body is formed, the lead body material is formed around the stem 846 and flange 850 of the chip electrode 840 to facilitate retention of the chip electrode within the lead body of the resulting lead. The flange 850 prevents the chip electrode 840 from coming off from the lead body. The portion of the lead body formed in the flange recess 852 and around the protrusion 854 can facilitate both holding the chip electrode on the lead and reducing the possibility of rotation of the chip electrode. Typically, non-circular flanges will have some resistance to tip electrode rotation.

  In at least some embodiments, a pre-electrode 840 'is prepared during manufacture, as shown in FIG. 8B. A lead body is formed around the pre-electrode 840 '. Next, the lead body and the pre-electrode 840 'are ground to obtain the chip electrode of FIG. 8A. This grinding process also removes excess lead body material, leaving a lead body of the desired diameter.

  FIG. 9A shows one embodiment of a tip electrode 940 having an electrode body 942 and a lumen 941. The electrode body 942 includes at least a portion of a surface that is exposed to tissue to stimulate the tissue when the lead is implanted. When the lead body is formed, the lead body material flows into the lumen 941 to facilitate retention of the electrode on the lead body of the resulting lead. The tip electrode 940 has a protrusion 956 on the surface defining the lumen 941. These protrusions 956 facilitate the holding of the chip electrode in the lead body and also resist the rotation of the chip electrode around the lead body. In the illustrated embodiment, the pattern of protrusions 956 forms a star-shaped cross-section, but the regular and irregular shapes created by the protrusions into the lumen are used to form the tip electrode around the lead body. It should be recognized that it can resist rotation.

  Further, the proximal end of the tip electrode 940 has a non-circular opening 958 with a protrusion 956 ′ that forms a flange to the adjacent portion 960 of the inner surface of the tip electrode 940 that defines the lumen 941. These protrusions 956 'and the resulting flange-like structure resist rotation of the tip electrode around the lead body and resist removal of the tip electrode from the distal end of the lead.

  The tip electrode conductor (not shown) may be attached to any portion of the tip electrode including, but not limited to, the tip end of the tip electrode, the protrusion 956 ', or the surface defining the lumen 941. it can. In at least some embodiments, a pre-electrode 940 'is prepared during manufacture, as shown in FIG. 9B. A lead body is formed around and within the pre-electrode 940 '. Next, the lead body and the pre-electrode 940 'are ground to obtain the chip electrode 940 of FIG. 9A. This grinding process also removes excess lead body material, leaving a lead body of the desired diameter. It should be understood that this embodiment can be modified to include a base having a lumen and a separation plug, as shown in FIGS. 5-6B.

  FIG. 10A illustrates one embodiment of a tip electrode 1040 having an electrode body 1042, a lumen 1041, and a plurality of arms 1060 extending over the entrance 1064 from the electrode body 1042 to the lumen 1041. FIG. The electrode body 1042 includes at least a portion of a surface that is exposed to tissue to stimulate the tissue when the lead is implanted. When the lead body is formed, the lead body material flows into the lumen 941 to facilitate retention of the tip electrode within the lead body of the resulting lead. These arms 1060 facilitate the retention of the chip electrode in the lead body and also resist the rotation of the chip electrode around the lead body. In the illustrated embodiment, the tip electrode 1040 has three arms 1060, but any number of arms, including but not limited to one, two, three, four, six, or more arms. It should be recognized that can be used. The arms 1060 can be distributed in any regular or irregular arrangement around the edge of the electrode body 1042.

  The tip electrode conductor (not shown) can be attached to any portion of the tip electrode including, but not limited to, the tip end of the tip electrode, the arm 1060, or the surface defining the lumen 1041. . In at least some embodiments, a pre-electrode 1040 'is prepared during manufacturing, as shown in FIG. 10B. A lead body is formed around and within the pre-electrode 1040 '. Next, the lead body and the pre-electrode 1040 'are ground to obtain the chip electrode 1040 of FIG. 10A. This grinding process also removes excess lead body material, leaving a lead body of the desired diameter. It should be understood that this embodiment can be modified to include a base having a lumen and an arm and a separation plug, as shown in FIGS.

  The above specification, examples and data provide a description of the manufacture and use of the composition of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention also resides in the claims hereinafter appended.

Claims (12)

  1. An implantable electrical stimulation lead,
    A lead body including a distal portion, a distal tip, and a proximal portion;
    A plurality of electrodes disposed along a distal portion of the lead body, the plurality of electrodes including a tip electrode disposed at a distal tip of the lead body, wherein the tip electrode is electrically conductive And a conductive isolation plug attached to the base , wherein the base and a portion of the isolation plug are exposed to an outer surface of the electrical stimulation lead, and the base has a lumen One end of the lumen is closed by the plug and a portion of the lead body extends into the lumen of the base;
    A plurality of terminals disposed along a proximal portion of the lead;
    A plurality of conductors, each of said conductors electrically coupling at least one of said electrodes to at least one of said terminals.
  2. The implantable electrical stimulation lead of claim 1, wherein the base is in electrical communication with the isolation plug.
  3.   The implantable electrical stimulation lead of claim 1, wherein the plurality of electrodes further comprises a plurality of segment electrodes.
  4.   The implantable electrical stimulation lead of claim 3, wherein the plurality of electrodes further comprises at least one ring electrode.
  5. The implantable electrical stimulation lead of claim 1, wherein the base and the isolation plug have sloped edges that facilitate mating of the base and the isolation plug.
  6. Further, a plurality of projections extending into the lumen, a plurality of projections of said lumen, said at about the distal tip of facilitate and said lead body retention of the tip electrode in the lead body Ru prevents the rotation of the tip electrode, implantable stimulation lead of claim 1.
  7. 7. The implantable of claim 6 , wherein the base further comprises an opening into the lumen, the opening having a plurality of protrusions formed around the opening and imparting a non-circular shape to the opening. Electrical stimulation lead.
  8. The implantable electrical stimulation lead according to claim 7 , wherein the plurality of protrusions formed around the opening constitute a flange-like structure to a surface of the lumen adjacent thereto.
  9. The implantable electrical stimulation lead of claim 6, wherein the plurality of protrusions comprise a star-shaped cross section.
  10. The tip electrode comprises a plurality of arms extending from said base, having an opening into the lumen, said plurality of arms extend over the opening into the lumen, a portion of the lead body, said base It extends around and said plurality of arms extending into the lumen of the plurality of arms, to facilitate retention of the tip electrode in the lead body, implantable electrical stimulation lead of claim 1.
  11. The implantable electrical stimulation lead of claim 10 , wherein the arms are arranged at regular intervals around the base .
  12. The implantable electrical stimulation lead of claim 10 , wherein the plurality of electrodes further comprises a plurality of segment electrodes.
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